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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00161824
Other study ID # 208
Secondary ID
Status Completed
Phase Phase 3
First received September 8, 2005
Last updated May 20, 2015
Start date October 2001
Est. completion date January 2002

Study information

Verified date May 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.


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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind


Related Conditions & MeSH terms


Intervention

Biological:
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)


Locations

Country Name City State
Poland Zespol Opieki Zdrowotnej w Debicy Debica
Poland Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A Kielce
Poland "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego Krakow
Poland Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta" Krakow
Poland Szpital Jana Pawla II Oddzial Neuroinfekcji Krakow
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny Lubartow
Poland PANTAMED sp. z o.o. Olsztyn

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Poland, 

See also
  Status Clinical Trial Phase
Terminated NCT01031537 - Vaccine Study for Tick-Borne Encephalitis Virus (TBEV) Phase 2
Completed NCT00460486 - Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule Phase 3
Completed NCT00161967 - TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209) Phase 4
Completed NCT00163540 - Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225) Phase 4
Completed NCT00161876 - FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years Phase 3
Recruiting NCT03932448 - Fever After Tick Bite Study
Completed NCT00311441 - Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children Phase 4
Completed NCT00161954 - Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years Phase 4
Completed NCT00163618 - Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children Phase 4
Completed NCT00503529 - TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223) Phase 4
Completed NCT00840801 - Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children Phase 3
Completed NCT00452621 - Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years Phase 4
Completed NCT00311493 - Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults Phase 4
Completed NCT00161889 - FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years Phase 2
Completed NCT00161850 - FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years Phase 2
Completed NCT00894686 - Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401) Phase 4
Completed NCT00161746 - Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years Phase 2/Phase 3